- Ivonescimab combined with chemotherapy showed a significant improvement in progression-free survival in patients with EGFR-mutant non-small cell lung cancer (NSCLC) after EGFR TKI therapy.
- Summit Therapeutics (SMMT, Financial) considers filing a Biologics License Application (BLA) in the US following these positive results.
- No new safety concerns emerged, with manageable adverse events noted in the study.
Summit Therapeutics Inc. (SMMT) has announced promising results from its Phase III HARMONi trial, which evaluated the combination of ivonescimab plus chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, non-squamous non-small cell lung cancer (NSCLC). The results demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy alone, with a hazard ratio of 0.52 (95% CI: 0.41 – 0.66; p<0.00001).
The HARMONi study included multiregional participation, involving patients who had progressed after treatment with a 3rd generation EGFR tyrosine kinase inhibitor (TKI). Consistent benefits in PFS were observed across both Asian and Western population groups, confirming the efficacy of the ivonescimab-chemotherapy regimen across diverse demographics.
While the study also showed a positive trend in overall survival (OS) with a hazard ratio of 0.79 (95% CI: 0.62 – 1.01; p=0.057), this did not reach statistical significance. Nevertheless, these results highlight ivonescimab’s potential in addressing unmet medical needs for this patient group, where currently no FDA-approved regimens have demonstrated a statistically significant OS benefit.
Regarding safety, the treatment was well-tolerated, with Grade 3 or higher treatment-emergent adverse events occurring in 56.9% of patients in the ivonescimab arm compared to 50.0% in the chemotherapy-alone group.
With these findings, Summit Therapeutics intends to evaluate the timing of a potential Biologics License Application (BLA) filing with the US Food and Drug Administration (FDA). The company emphasizes the need for a statistically significant overall survival benefit to support marketing authorization, as advised by the FDA.
